FDA has agreed to key aspects of the clinical program, including the primary endpoint for the single pivotal phase 3 study
There are approximately 175,000 and 150,000 ESKD patients with PAD in the USA and Europe respectively with no approved treatments
Palma, Spain and San Diego, USA, 20 July 2020 – Sanifit, a clinical-stage biopharmaceutical company developing treatments for calcification disorders, announces today that it will start a new clinical development program to investigate the effect of SNF472 in End Stage Kidney Disease (ESKD) patients with Peripheral Artery Disease (PAD), a cardiovascular disease affecting peripheral arteries by reducing blood flow to the limbs.
PAD leads to reduced mobility, pain in lower extremities, and can lead to limb-threatening ischemia and amputation. One distinguishing feature of PAD in ESKD is a profound degree of arterial calcification, with PAD prevalence in patients on chronic hemodialysis reported to be as high as 37%.
The clinical program will consist of a cross-sectional study, planned to commence in Q3 2020, in a target population of ESKD patients with PAD. This will be followed by a single pivotal Phase 3 study planned for 2021.
The clinical program was discussed with the FDA at a recent Type C meeting. The agency acknowledged that PAD in ESKD represents a significant unmet medical need and agreed with the key aspects of the program, including the primary endpoint for the pivotal study and supportive analyses. The design and protocol of the Phase 3 study will be finalized after completion of the cross-sectional study.
Results of a Phase 2b randomized placebo-controlled study (CaLIPSO) presented at the American Heart Association (AHA) in 2019 and published in the AHA journal Circulation demonstrated that SNF472 reduced progression of coronary artery calcium compared with placebo (Raggi, 2020), and thus may lead to clinical benefit in cardiovascular diseases such as PAD. SNF472 has also been shown to be associated with improved wound healing and pain in a Phase 2 study in patients with calciphylaxis and is currently in Phase 3 study (CALCIPHYX).
Joan Perelló, Chief Executive Officer of Sanifit, said: “We are excited to investigate SNF472 in this severe condition for which there are currently no treatment options. Given the prominent role of calcification in this disease, the clinical and preclinical data, we believe SNF472 has potential for clinical benefit.”
Dr. William Hiatt, Professor of Medicine (Cardiology) at University of Colorado and CPC Clinical Research (a University-affiliated academic research organization) commented: “PAD is a very serious condition leading to significant complications in ESKD patients on dialysis with increased morbidity and mortality. PAD causes deterioration in walking ability, quality of life, and ultimately increases the overall risk of amputation and death. There is currently no effective treatment for ESKD patients suffering from PAD, and prior clinical trials have excluded these patients. This clinical program therefore represents a great opportunity to build on the promising data showing the ability of SNF472 to inhibit vascular calcification, a major driver of disease in these patients and investigate its ability to improve function and quality of life in these patients.”
– – –
More about Sanifit: www.sanifit.com